HOW TO WRITE SOPs - 7 July 2014 IMPROVING PROCESSES & CAPA - 8 July 2014 tion to Applicaister Reg Please PRINT your details: Title .................. First Name........................................... (Dr, Mr, Mrs, etc) Family name ................................................................... Position ........................................................................... Department..................................................................... Company ........................................................................ Company VAT No. .......................................................... Address .......................................................................... ........................................................................................ City ................................ Post Code ............................. Country........................................................................... Tel No. ............................................................................. Fax No............................................................................. E-mail ............................................................................. Secretary’s Name ........................................................... Payment by either: VISA MASTERCARD AMEX Card No. (PLEASE READ CAREFULLY) Dates An Essential Course for Ensuring Compliance with Regulatory Requirements Registra tion Informati on How to Write SOPs – 7 July 2014 Reg & Coffee - Start 09.30 – Finish – 17.00 Ref: A7-4314 Improving Processes & CAPA – 8 July 2014 Reg & Coffee - Start 09.30 – Finish – 17.00 Ref: A7-4414 Venue and Accommodation The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS Hotel Tel: +44(0)20 7589 8100 Hotel Fax:+44(0)20 7225 3476 Email: reservations_rembrandt@sarova.co.uk Subject to availability, a limited number of bedrooms have been reserved at the hotel at a special rate. All bookings should be made directly with the hotel or online at www.sarova.com/rembrandt, quoting promo code ‘manforum’. Particularly relevant for Pharmacovigilance, Regulatory Affairs, Clinical Research/Operations, GMP and Data/Document Management Functions f nt i r cou gethe s i D o t ked boo AMEX Expiry date........../......... Conference Fee if individual seminars booked £575 + VAT if applicable* Tick here to register Conf. No. A7-4314 £575 + VAT if applicable* Tick here to register Conf. No. A7-4414 Special discounted rate available if both seminars booked together £1100 + VAT if applicable* Conf. Nos. A7-4314 & A7-4414 Tick here to register Cheque enclosed payable to Management Forum Limited Bank transfer on receipt of invoice +44 (0) 1483 730008 Management Forum Ltd To Reg is ter www.management-forum.co.uk E-mail: registrations@management-forum.co.uk If you have NOT received confirmation seven days after registering, please contact Registration Department. Cancellation Policy: Over 14 days prior to the Seminar: Cancellation fee of £75. 7/14 days prior to the Seminar: 50% of the fee. Fewer than 7 days or if no notification received: Registrant liable to pay FULL seminar fee. NB: Cancellations must be received in writing by registrations@management-forum.co.uk Management Forum reserves the right to cancel/ alter the programme, the speakers, the date or venue. If an event is cancelled Management Forum is not responsible for airfare, hotel or other costs incurred by registered delegates. For Promotional Opportunities email: robert@management-forum.co.uk If you do not want to receive future mailings from Management Forum please contact nick@management-forum.co.uk If you do not wish to receive selected third party mailings please contact nick@management-forum.co.uk MANAGEMENT FORUM LTD, 98-100 Maybury Road, Woking, Surrey GU21 5JL, UK Tel: +44 (0)1483 730071 Fax: +44 (0)1483 730008 Website: www.management-forum.co.uk n n n n n How to Write Concise and User Friendly SOPs How to Prepare the Topic Content of SOPs Implement and Manage SOPs Effectively Effective SOP Training Ensure your SOPs Incorporate Appropriate Regulatory Requirements Dr Laura Brown, Independent Pharmaceutical QA Consultant, the Course Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff and Course Director, MSc Regulatory Affairs, TOPRA. Opposite V&A Museum. Nearest underground station: South Kensington. www.sarova-rembrandthotel.com/location-local-attractions Discounted Rates Available on application for personnel from non-profit making organisations and registered charities. Group discount available on request Topics to be covered include: With Directions 7 July 2014 - The Rembrandt Hotel, London *The fee includes course documentation as well as mid-session refreshments and lunch. Invoice and confirmation will be forwarded to you. Card Security No. ß HOW TO WRITE SOPs W JOIN US ON IMPROVING PROCESSES AND CAPA (CORRECTIVE AND PREVENTATIVE ACTION) Topics to be covered include: n Understand CAPA Methodology and Documentation n Learn Tools and Techniques to Help Make your Existing Processes more Efficient and Compliant n Discover how you can Address Inspection Findings using CAPA and Process Improvement n How to Develop Options for Process Improvement and CAPA n Planning and Implementation in Practice of Improvements and CAPA With Dr Laura Brown, Independent Pharmaceutical QA Consultant and the Course Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff 8 July 2014 - The Rembrandt Hotel, London HOW TO WRITE SOPs INTRODUCTION 7 July 2014 SOPs play a crucial role in compliance with regulations. It is therefore essential that they are well written and easy to use by the end-users. If SOPs are not followed correctly, the validity of data generated is compromised, leading to inspection findings and non compliance issues which could lead to delays in bringing a drug/device to market. This SOP course has been specifically designed to help you develop the skills to write, produce the content of SOPs, review and implement SOPs and in particular to be able to comply in a regulated environment. It is essential therefore to have a number of SOPs, and for existing SOPs to be reviewed and updated regularly. Otherwise this is likely to result in major findings by regulatory inspectors. Participants will come away with the confidence to use a process to write, update and implement SOPs which can easily be used by the end users. WHO SHOULD ATTEND • • • All those in Pharma, Biotechnology, Devices and Veterinary industries who will be or are involved in preparing, reviewing and/or managing SOPs Ideal as an introduction to preparing, reviewing and implementing SOPs and may also be helpful to those wanting to ensure they are aware of best practice Particularly those in GXP areas including clinical research, pharmacovigilance, regulatory affairs and GMP u Introduction and Objectives uHow to Write Concise and User Friendly SOPs • When are SOPs needed and why? • What is the difference between having SOPs and work instructions/local guidance? • Format, content, style and presentation • Translation of the activities into the SOPs • Writing sufficiently detailed SOPs, but which are not restrictive • Defining SOP content using mind mapping and flow charting • Review and approval processes for SOPs 8 July 2014 COURSE LEADER INTRODUCTION COURSE LEADER Dr Laura Brown is an Independent Pharmaceutical QA and training Consultant and the Course Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff. Laura is a recognised expert in QA and training. She has more than 19 years experience in the pharmaceutical industry in a number of senior roles and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in several Quality Assurance roles which have included writing and reviewing SOPs and has helped companies implement the regulatory requirements of changes in regulations. In today’s highly regulated Pharma, Device and Veterinary industries, it is essential to use the most efficient processes and ensure compliance with Corrective and Preventative Action (CAPA). Regulatory Inspectors are increasing reviewing responses to findings dealt with by the CAPA approach and process improvement. Dr Laura Brown is an Independent Pharmaceutical QA and training Consultant and the Course Director for the MSc Clinical Research, School of Pharmacy, University of Cardiff. IN-HOUSE COURSE This seminar is also available as an in-house course, and can if required be tailored to your specific needs. For further information please contact Sarah Spanswick – sarah@management-forum.co.uk Certificates of Attendance for Professional Development will be given to each participant who completes these seminars Register on-line at www.management-forum.co.uk or telephone +44 (0) 1483 730071 • • • • • It is highly likely that the organisations who have already been inspected will be assessed at next inspection in terms of whether the corrective and preventative actions have been implemented – has the organisation done what they said they would? If previous major findings have not been addressed then a critical finding may be given. This course will be ideal for you to learn how to improve industry procedures and processes and how to implement and document an effective CAPA quality system. WHO SHOULD ATTEND The course has been specifically designed for the Pharma, Biotechnology, Devices and Veterinary industries and particularly if you are involved in process improvement, corrective and preventative action, problem solving and managing inspections and documenting how to deal with these. Laura is a recognised expert in QA and training. She has more than 19 years’ experience in the pharmaceutical industry in a number of senior roles and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. IN-HOUSE COURSE This seminar is also available as an in-house course, and can if required be tailored to your specific needs. For further information please contact Sarah Spanswick – sarah@management-forum.co.uk Certificates of Attendance for Professional Development will be given to each participant who completes these seminars Register on-line at www.management-forum.co.uk or telephone +44 (0) 1483 730071 PROGRAMME PROGRAMME uSOP Implementation and Management IMPROVING PROCESSES & CAPA Handling updates – when should SOPs be updated and how? Distribution, version control SOP training How to maximise end user compliance Tips for what auditors and inspectors look for when they review SOPs u Ensuring your SOPs include Appropriate Regulatory Requirements and Objectives • What level of regulatory requirements should be in SOPs? • What topics should the SOPs cover? • What needs to be included for compliance? - GxP areas including clinical research, pharmacovigilance, regulatory affairs and GMP uFinal Questions and Close u Introduction and Objectives u Developing Options for Process Improvement and CAPA uCAPA Methodology and Documentation • Identification – clearly define the problem • Evaluation – appraise the magnitude and impact, e.g. scenarios, test out assumptions (e.g. using the Uncertainty – Importance grid to help identify potential risks) • Investigation • Analysis – perform a thorough assessment – review data, prioritise, develop options for solutions • Action Plan – create a list of required tasks • Implementation – execute the action plan, e.g. stakeholder analysis, the transition curve • Follow Up – verify and assess the effectiveness of the CAPA • Finding(s) uDiagnosing Process Improvement • Using problem diagnosis (for example, “root cause” analysis) for understanding why processes are cumbersome and to help facilitate resolving audit and inspection findings • • • Being more creative in problem solving of process simplification issues Evaluation of the attractiveness/likely difficulty of changes (“AID” analysis) Continuous improvement teams – as an invaluable approach for improving the implementation of regulatory change uPlanning and Implementation in Practice of Improvements and CAPA • • • Project managing process improvements and CAPA Managing the change and people issues Managing the stakeholders involved (stakeholder analysis) uFinal Questions and Close